Relationship of nimesulide safety to its pharmacokinetics: assessment of adverse reactions

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely us ed drugs and their use is frequently associated with severe or even serious adverse events, which increase morbidity and mortality. The increase of to xic effects, primarily of the digestive system, due to treatment with NSAID s, underlines a need for safer NSAIDs Nimesulide (4-nitro-2-phenoxymethanes ulphonanilide) is a chemically unique anti-inflammatory agent in that it ha s a higher pK(a) (6.5) than conventional acidic NSAIDs and it is one of the newer class of NSAIDs that are selective for cyclooxygenase-2. Nimesulide also has additional activities, among them effects on production/action of oxy-radicals and other components of neutrophil activation that may contrib ute to the spectrum of its anti-inflammatory activity as well as potentiall y reducing the likelihood of gastrointestinal ulcerogenicity. An analysis w as performed of the safety data of nimesulide collected in clinical studies and from those reported spontaneously worldwide in the post-marketing phas e. The results show that nimesulide is associated with a relatively low occ urrence of adverse drug reactions especially in the gastrointestinal tract while those in the liver are within or below the general incidence with oth er NSAIDs.